Atherosclerosis Coronary Artery With Angina PectorisNCT04835467
First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI
A study testing Dual-modal OCT-FLIm in people with Atherosclerosis Coronary Artery With Angina Pectoris and Atheroscleroses, Coronary, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atherosclerosis Coronary Artery With Angina Pectoris, Atheroscleroses, Coronary, Atherosclerotic Plaque
- What is being tested?
- Dual-modal OCT-FLIm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Feb 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: greater than 20, less than 80
- Patients with significant coronary artery disease (diameter stenosis >70%) requiring coronary revascularization
- Reference vessel diameter: between 2.5 and 4.0 mm
- Obtained informed consent from voluntary participants before study enrollment
Who cannot join
- Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
- Reference vessel diameter: less than 2.5 mm, greater than 4.0 mm
- Coronary lesion with heavy calcification
- Hemodynamic instability during coronary intervention
- Contraindication to antithrombotic therapy
- Chronic renal insufficiency (Serum creatinine >2.0mg/dL)
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- Severe liver dysfunction (AST/ALT > 5 times of upper normal limit)
- Pregnancy or potential pregnancy
- Life expectancy less than 1 year
- Patient refused to sign the informed consent at enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention
Patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.
Read the detailed description
Fluorescence lifetime imaging (FLIm) is a novel imaging approach allowing label-free biochemical characterization of atherosclerotic plaque. A combined optical coherence tomography (OCT) and FLIm that can provide a simultaneous structural and biochemical assessment of atheroma has been constructed successfully. This study sought to investigate whether the dual-modal intravascular OCT-FLIm is able to characterize high-risk plaques in patients undergoing percutaneous coronary intervention.
Forty patients with multivessel coronary artery disease, who had at least one obstructive lesion (>70% diameter stenosis) that is considered suitable for PCI, will be included in the study. Culprit and mildly stenotic non-culprit plaques will be imaged using OCT-FLIm catheter.
Six-month follow-up assessment is systematically scheduled in all patients to assess temporal changes in FLIm signatures according to treatment strategies (medical therapy, interventional therapy etc).
- Conditions
- Atherosclerosis Coronary Artery With Angina Pectoris, Atheroscleroses, Coronary, Atherosclerotic Plaque, Thin-cap fIbroatheroma, Atherosclerosis
- Being tested
- Dual-modal OCT-FLIm
- Keywords
- Fluorescence lifetime imaging, High-risk coronary plaque, Optical coherence tomography, Intravascular imaging, Biochemical imaging
- Medical subject headings
- Coronary Artery Disease, Plaque, Atherosclerotic, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-modal OCT-FLImDevice
Intracoronary imaging using dual-modal OCT-FLIm catheter
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary imaging | Experimental | Intracoronary imaging during PCI Receives: Device: Dual-modal OCT-FLIm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)
Difference in fluorescence lifetime measurement reflecting plaque inflammation according to pre-specified plaque subtypes
Measured: day 1
Secondary outcomes (2)
Fluorescence lifetime measurement of healed plaque in the target/culprit or non-target/non-culprit lesion (nanosecond)
Difference in fluorescence lifetime measurement reflecting healed property according to pre-specified plaque subtypes
Measured: day 1
Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)
Difference in fluorescence lifetime measurement reflecting superficial calficiation according to pre-specified plaque subtypes
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start14 Feb 2022
- Primary completion18 Aug 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atherosclerosis Coronary Artery With Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group patient enrollment and scheduled 6-month follow-up assessment
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Won Kim, Korea University Guro Hospital
- Investigators
- Sunwon Kim, MD, PhD, Study director, Korea University Ansan HospitalDong Oh Kang, MD, PhD, Study director, Korea University Guro HospitalJin Won Kim, MD, PhD, Principal investigator, Korea University Guro HospitalHongki Yoo, PhD, Study director, Korea Advanced Institute of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835467
- Sponsor's protocol ID
- SRFC-IT1501-05
- Status last verified
- Nov 2023
- First submitted
- 5 Apr 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee MW, Song JW, Kang WJ, Nam HS, Kim TS, Kim S, Oh WY, Kim JW, Yoo H. Comprehensive intravascular imaging of atherosclerotic plaque in vivo using optical coherence tomography and fluorescence lifetime imaging. Sci Rep. 2018 Sep 28;8(1):14561. doi: 10.1038/s41598-018-32951-9.
PubMed 30267024Kim S, Yoo H, Kim JW. Long Journey of Intravascular Imaging: What and How to Look at the Atheroma in Coronary Artery. JACC Cardiovasc Imaging. 2021 Sep;14(9):1843-1845. doi: 10.1016/j.jcmg.2020.11.015. Epub 2020 Dec 16. No abstract available.
PubMed 33341412Nam HS, Kang WJ, Lee MW, Song JW, Kim JW, Oh WY, Yoo H. Multispectral analog-mean-delay fluorescence lifetime imaging combined with optical coherence tomography. Biomed Opt Express. 2018 Mar 27;9(4):1930-1947. doi: 10.1364/BOE.9.001930. eCollection 2018 Apr 1.
PubMed 29675330
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04835467
- Acronym / sponsor ID
- SRFC-IT1501-05
- Conditions
- Atherosclerosis Coronary Artery With Angina Pectoris, Atheroscleroses, Coronary, Atherosclerotic Plaque, Thin-cap fIbroatheroma, Atherosclerosis
- Keywords
- Fluorescence lifetime imaging, High-risk coronary plaque, Optical coherence tomography, Intravascular imaging, Biochemical imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.
Detailed description
Fluorescence lifetime imaging (FLIm) is a novel imaging approach allowing label-free biochemical characterization of atherosclerotic plaque. A combined optical coherence tomography (OCT) and FLIm that can provide a simultaneous structural and biochemical assessment of atheroma has been constructed successfully. This study sought to investigate whether the dual-modal intravascular OCT-FLIm is able to characterize high-risk plaques in patients undergoing percutaneous coronary intervention.
Forty patients with multivessel coronary artery disease, who had at least one obstructive lesion (>70% diameter stenosis) that is considered suitable for PCI, will be included in the study. Culprit and mildly stenotic non-culprit plaques will be imaged using OCT-FLIm catheter.
Six-month follow-up assessment is systematically scheduled in all patients to assess temporal changes in FLIm signatures according to treatment strategies (medical therapy, interventional therapy etc).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group patient enrollment and scheduled 6-month follow-up assessment
| Arm | Type | Receives |
|---|---|---|
| Intracoronary imaging | Experimental | Device: Dual-modal OCT-FLImIntracoronary imaging during PCI |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: greater than 20, less than 80
- Patients with significant coronary artery disease (diameter stenosis >70%) requiring coronary revascularization
- Reference vessel diameter: between 2.5 and 4.0 mm
- Obtained informed consent from voluntary participants before study enrollment
Key exclusion criteria (10 listed)
- Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
- Reference vessel diameter: less than 2.5 mm, greater than 4.0 mm
- Coronary lesion with heavy calcification
- Hemodynamic instability during coronary intervention
- Contraindication to antithrombotic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-modal OCT-FLImIntracoronary imaging using dual-modal OCT-FLIm catheter | Device | Intracoronary imaging |
Primary outcome
Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)
Time frame: day 1
Difference in fluorescence lifetime measurement reflecting plaque inflammation according to pre-specified plaque subtypes
2 secondary outcomes
Fluorescence lifetime measurement of healed plaque in the target/culprit or non-target/non-culprit lesion (nanosecond)
Time frame: day 1
Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Background: PubMed 30267024Lee MW, Song JW, Kang WJ, Nam HS, Kim TS, Kim S, Oh WY, Kim JW, Yoo H. Comprehensive intravascular imaging of atherosclerotic plaque in vivo using optical coherence tomography and fluorescence lifetime imaging. Sci Rep. 2018 Sep 28;8(1):14561. doi: 10.1038/s41598-018-32951-9.
- Background: PubMed 33341412Kim S, Yoo H, Kim JW. Long Journey of Intravascular Imaging: What and How to Look at the Atheroma in Coronary Artery. JACC Cardiovasc Imaging. 2021 Sep;14(9):1843-1845. doi: 10.1016/j.jcmg.2020.11.015. Epub 2020 Dec 16. No abstract available.
- Background: PubMed 29675330Nam HS, Kang WJ, Lee MW, Song JW, Kim JW, Oh WY, Yoo H. Multispectral analog-mean-delay fluorescence lifetime imaging combined with optical coherence tomography. Biomed Opt Express. 2018 Mar 27;9(4):1930-1947. doi: 10.1364/BOE.9.001930. eCollection 2018 Apr 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunwon Kim, MD, PhD study director
Korea University Ansan Hospital
Dong Oh Kang, MD, PhD study director
Korea University Guro Hospital
Jin Won Kim, MD, PhD principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-modal OCT-FLIm in people with Atherosclerosis Coronary Artery With Angina Pectoris and Atheroscleroses, Coronary, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond) (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835467, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.